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临床试验/NCT04507464
NCT04507464已完成不适用

A Physical Activity Program to Disrupt Sedentary Time in Older Latinos

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2020年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Time in Sedentary Bouts

研究概览

简要总结

To test the feasibility of an intervention designed to replace sedentary time with physical activity in older Latinos, delivered in their homes to improve cognitive function and brain connectivity.

详细描述

After being informed of the study and potential risks, all patients giving informed consent will undergo a focused phone interviews, followed by screening to determine eligibility. Participants that meet inclusion criteria will undergo baseline cognitive function testing via video (following NIH toolbox guidelines for remote cognitive function assessment), followed by a one week measurement of sedentary time using a physical activity monitor (actigraphy). At week 0, participants will be randomized into either a physical activity group to break up sedentary time or activity guidelines only in a 1:1 ratio. Follow up occurs at 6 weeks using the same measures as baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •no history of major head trauma
  • •ownership of a smartphone
  • •ability to make video calls

排除标准

  • •Requires assistive ambulation;
  • •Unstable angina,
  • •Claudication
  • •severe arthritis,
  • •extreme dyspnea on exertion,
  • •Class III-IV heart failure;
  • •Current uncontrolled sustained arrhythmias,
  • •severe/symptomatic aortic or mitral stenosis,
  • •hypertrophic obstructive cardiomyopathy,
  • •severe pulmonary hypertension,
  • •active myocarditis/pericarditis,
  • •thrombophlebitis,
  • •recent systemic/pulmonary embolus (within 3 months);
  • •Revascularization procedures within the previous 6 months;
  • •Pregnancy

研究组 & 干预措施

Ecological Momentary Intervention

Experimental

Participants will receive real time physical activity notifications via a wearable activity tracker and smartphone application.

干预措施: Ecological Momentary Intervention (Behavioral)

Physical Activity Guidelines

No Intervention

Participants will be sent general guidelines for disruption of sedentary time.

结局指标

主要结局

Time in Sedentary Bouts

时间窗: Baseline, 6 weeks

Change from baseline to 6 weeks in minutes spent in sedentary bouts

Number of Sedentary Bouts

时间窗: Baseline, 6 weeks

Change in number of bouts of sedentary activity at 6 weeks from baseline. One sedentary bout is defined as a 10 minute bout or longer where the activity count is less than 99 counts per minute. Sedentary Bout Parameters Minimum Length: 10 Minutes Minimum Count Value: 0 Counts Per Minute Maximum Count Value: 99 Counts Per Minute

次要结局

  • Difficulty Understanding Text Messages(6 weeks)
  • Difficulty With the FitBit.(6 weeks.)
  • Trail Making Test A(Baseline, 6 weeks)
  • List Sorting(Baseline, 6 weeks)
  • Enjoyment of the Text Messages.(6 weeks.)
  • Text Messages Helping Exercise.(6 weeks.)
  • Trail Making Test B(baseline, 6 weeks)
  • Picture Vocabulary Test(Baseline, 6 weeks)
  • Picture Sequence(Baseline, 6 weeks)
  • Oral Reading Recognition Test(Baseline, 6 weeks)
  • Auditory Verbal Learning(Baseline, 6 weeks)
  • Crystalized Cognition(Baseline, 6 weeks)
  • Text Message Motivation.(6 weeks.)
  • Enjoyment of the Program.(6 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulf G. Bronas

Associate Professor

University of Illinois at Chicago

研究点 (1)

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